Many MedTech startups and innovators focus heavily on core technology development, often assuming physical product design is simple polishing once a working concept exists. Michael Sprauve explains that this approach frequently creates a gap between brilliant engineering and a market-ready, commercially viable medical device. Succeeding in hardware requires looking past the technology to consider every individual who will interact with the device throughout its entire lifecycle.
A critical challenge in MedTech design is managing the complex web of user personas involved. Unlike consumer electronics, where design caters to one or two primary end users, medical devices must meet the needs of surgeons, operating room staff, post-surgical nurses, maintenance technicians, disposal personnel, and regulatory bodies. Overlooking support staff—such as nurses managing crowded, alarm-fatigued rooms or technicians handling biological waste and lithium-ion batteries—can derail an otherwise promising device.
As AI image generation tools become widespread, creators increasingly present AI-rendered concepts as finished designs. While these tools offer creative inspiration, they lack awareness of physical constraints, manufacturing rules, and real-world usability. By establishing a non-physical "North Star" based on emotional attributes and sensory cues, design teams can guide products through concepting, engineering, and manufacturing without losing sight of user needs and regulatory mandates.
Love this episode? Leave a review on iTunes!
Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
Design for Manufacturability is the practice of designing a product so that it is easy and cost-effective to manufacture.
CMF is a specialized area of industrial design that focuses on defining the external chromatic, tactile, and material properties of a physical product.
"With MedTech, there are actually several user personas. It's the surgeon, the operating room attendant, the nurses who maintain the device post-surgery, the team removing and disposing of it, and the regulatory body. Each one is critical." - Michael Sprauve
"AI doesn't have the capability today of really understanding the physical world. Clients come in married to an AI-generated vision, and our job is to gently peel back that emotional attachment to find the underlying North Star." - Michael Sprauve
Feedback Call-to-Action
We want to hear from you! What challenges have you faced when balancing user feedback against clinical and regulatory requirements? Send your thoughts, topic suggestions, or questions to podcast@greenlight.guru. Every email goes directly to our team, and we personally review listener notes for future episodes.
This episode is brought to you by Greenlight Guru.
Navigating the transition from an early-stage hardware concept to an FDA-cleared device requires rigorous quality control and clinical data management. Greenlight Guru provides purpose-built Quality Management System (QMS) and Electronic Data Capture (EDC) solutions designed specifically for medical device companies. Whether you are conducting initial user research, executing DFM, or preparing regulatory submissions, Greenlight Guru helps you bring safe, life-changing devices to market faster. Learn more at greenlight.guru.
Etienne Nichols: Hey everyone, this is Etienne Nichols with the Global Medical Device Podcast. Thank you. Welcome back. Today we're going to be talking about a gap that we've seen a little bit in in medical devices, the brilliant design that people come up with and what actually makes sense to sell in the market, particularly maybe getting into how AI has impacted that brilliant devices and how people feel like you know, maybe the design work is done by the time they come to a design firm or by the time they actually put it in front of an engineer, and how that is impacting actual medical devices. My guest today to talk with me about this is Michael Sprauve, the president of Speck Design. He's a which is a firm that's been building hardware since 1996.
He has nearly three decades taking medical and life science products from sketch on a whiteboard to FDA cleared, manufacturing ready reality. Their work includes Microports to My System, the first China developed four arm laparoscopic robot to earn NMPA marketing approval and design and engineering work on intuitive surgical DaVinci and Ion platforms, which passed three point one million procedures in 2025. Michael didn't start in MedTech.
He spent his first fifteen years directing engineering at Xerox, co-founding Destiny Networks, where he scaled a team to sixty engineers building smart remote controls, a leading engineers at home, engineering at home director, where he turned an underperforming product line into a twenty two percent sales increase. He was six years at CTO of WAGIC after that, and then he acquired Spec at the start of COVID, where he's now spent almost eight years as president. So, three years of taking hardware from concept to shipping product across printers, connected homes, surgical robots.
Today I want to talk to you a little bit, Michael, about where MedTech hard hardware actually kind of starts. I don't know, some of the pitfalls they get into, what it actually takes to design under the some of the tightest constraints in the in the industry, the MedTech medical device industry. So welcome to the show. Really excited to have this conversation with you, Michael.
Michael Sprauve: Great. And thank you very much. really excited to talk to you and your listening audience out there. You know, it's interesting as you kind of went through my history, we've seen a lot transpire and in the design world, especially around medical devices. There there's been a big shift recently where a lot of medical device startups or even proving companies will come in with a view of what their device needs to be.
Okay, which is quite interesting because they have been focusing on the technology, right? The how it should perform. What they very rarely take into account until it's too late is who will be doing it, who will be using it. Not just the surgeons or the nurses but also the support staff, the technicians, the people that come in and that need to either replace the device, service the device, or eventually dispose of the device. And that's where there's a big gap. So, you know, without naming a few companies that we work with, they would come in with what they believe was a ready to take the FDA device, and they would say, hey, we just need some polishing up here.
Okay, and one of the things that I like to pride myself here as spec design is we have a pretty thorough development process. And it usually starts with user insights, user research. Now, what we find is especially with medical startups, they poured all their money into the technology development where they really didn't save much money left over for development taken into the manufacturing. And so typically they will come to us and say, you know what, we've already done our user research, we've already done our insights.
We really don't need anything. Well, I've been in this business long enough to know that's leading to a disaster’s road. So, what we have done is we will embed in our process, whether the client pays for it or not, we will embed in our process a light to medium dose of user insights and user research because I feel we owe it to the client to deliver the best product that it should be capable of. Okay, so that's really one of the first things. So, I'm gonna pause there and see if you have any questions.
Etienne Nichols: What I I'm just really curious if we just kind of follow this rabbit trail just a little bit. So, when you have those user insights, you've, you know, we talked about your background across multiple different industries. Now in MedTech, I'm curious if there's a difference or what those differences are when you're pulling those user insights in this industry versus another, or are there are there any little tips or thoughts that you have when it comes to MedTech specific, when it comes to those pulling those user insights?
Michael Sprauve: Yeah, so one of the biggest things is the user persona, right? Typically, if you're doing an industrial or consumer or commercial product, there's usually maybe one or two personas that you deal with, right? And that is the end customer who's going to use the device day in and day out, right? And you need to really touch their emotional component to really drive that home. with MedTech, there's actually several different ones, right?
The first one is, in the case of let's say a surgical device, it's the surgeon itself, right? Or the operating room attendant. Okay, that's usually the first person who gets enamored with the technology. So, they want this device because it has the latest tech, it performs what they need to do, makes their job easier.
Okay, and a lot of MedTech companies stop at that. What they don't realize is the next user persona that is equally as important, in fact in some cases I would say actually even more important, is the support staff, the s the nurses, right? The people who come post-surgery and they have to maintain this device, right? And a lot of times we see devices that are created that are very difficult for the nurse to maintain. Do you check up on to operate? Because if we look at today's world, nursing is way understaffed and overcommitted.
And so, what they need is a device that they can quickly check in on and either say, yep, it's working, or no, I need to attend to it, right. But that being said, what you don't want is five or ten devices in a room beeping, you know, flashing and everything, because then it just becomes overwhelming. So, you always have to look at the environment of what this device is going to be post-surgical.
Okay, and then the next user persona is the person who comes in and removes it and needs to prepare it for the next device, right? So, you have autoclaving, you have repackaging if it's if it's going to be used. A lot of people want it to be disposable. So now you have to deal with, again, depending upon the MedTech device, whether it is biologically contaminated and therefore has to be disposed of you know, correctly.
Whether it has batteries, everybody loves lithium-ion. They love this ability to recharge and everything. Well, it now becomes a very difficult device to dispose of. Okay? And so, you have really three distinct personalities, user personas. The fourth one is the regulatory body, right? And that is what protocol does this fit under?
What is the purchasing code that insurance companies can be built against, and you have to position the device specifically for that. And each one of those personas are very important when you go into design the device. Okay, where consumer industrial is maybe two, maybe three, where the third one is the buyer. Yeah.
Etienne Nichols: Well, you mentioned just well, you got a lot of several mentioned several things that make it this interesting to me. One of the things though I'm curious about is when you go through those user insights and you do that, and I like that you said we're gonna do this no matter what, you know, because they need it and it's much better to work for a customer who you know is gonna succeed in the long run. So, I mean that's a good for everybody. So those user insights, what are some things that you consistently come up with? You're like, man.
Just every single time you can pretty much guarantee just looking at it, this is gonna happen. any anything typically come to mind.
Michael Sprauve: Yeah, so I touched on the alarms, right? You know, FDA has a bunch of regulatory requirements around alarms, both auditory and visual. And so, a lot of people don't take that into account, right? They think an alarm is an alarm. Well, depending upon the target audience that's gonna use this, you need to have certain frequencies, you need to have certain visual cues because not everybody is not colorblind. There's certain areas around, you know, different when do you sound a warning versus this is critical versus everything is happy kind of alarm around that. So that's usually the biggest area a lot of MedTech companies’ kind of gloss over, you know, because they're really focused on the technology, they're and which is great technology.
But that is one of the things that they tend to kind of gloss over is the indication component. Okay. Okay, the that's the next thing is just post-surgical storage or use, right? Does it hang on an IV pole? Does it hang on a bed? and if it does, how much space is it claiming? That's another area that, you know, everybody thinks that their technology needs to be front and center.
Right. You know, again, just really taking that all to account because that's really gonna affect the packaging. That's gonna affect how we and when I say by package, I'm talking about the display the housing of the unit. Yeah. Okay. so those are usually the big low hanging fruit for us from.
Etienne Nichols: The other thing we kind of talked about when we were discussing this episode was how AI has changed the game a little bit. I would expect, you know, if you used to have somebody who draw something on a napkin and bring it to you, okay, we gotta decipher that.
And it's obvious. Okay, well, XYZ is gonna change. There's no three, you there's lots of different things. But now we have the ability to generate these impressive images. And you mentioned people come to you with, you know, I assume my device, this is all it is, just pick out a material and let's start injection molding these housings, you know, that just like the picture. I'm guessing that's what it is. And if it's not, tell me something different. But what is it you're experiencing and seeing from the industry right now?
Michael Sprauve: So, I would love to tell you that it's something different, but it really is that and don't get me wrong, we're on the cusp of a new revolution when it comes to AI generation and product development, right? And we're trying to stay on the forefront of it. But with any revolution, there's gonna be starts and stops, there's gonna be bumps along the road.
One of the earliest things that we're seeing is as you ex as you aptly pointed out, people will, you know, start off the introduction with, hey, this is my product, just finish it up and we're good to go. But one of the things that AI hasn't taken account is the reality of physical constraints, right? They do it doesn't take in account, okay, we need this particular dimensional characteristics.
To fit all the stuff that they want. So, they come up with a beautiful look in peace, but it's not physically realistic. Okay. because again, AI doesn't have the capability today of really truly understanding the physical world. But that being said, the other issue and the more subtle one, and this is probably the more difficult one that requires a little bit more conversation with the client is they come in with their design and they are married to that design. They believe they have visualized what they see in their mind now in an image. And so, to go to that customer and to slowly but subtly divorce them of that image requires a little bit more hand holding and gentle persuasion.
And one of the big reasons why that is, is because what they have created is their vision for the product. What it doesn't take in account is the end user, all those user personas that I talked about earlier. It's not their vision. It's the creator's vision. Okay. And just like with Frankenstein, when he created the monster, he looked at something that he thought was.
This is incredible. Look at this technology that I have achieved. But obviously, as we know in the story, when the monster got out, everybody saw this hideous piece and rejected it. Okay. I'm not saying that these images are the monster from Frankenstein, but there's that disconnect of when someone comes in there, they are completely wedded to this image. And we now have to peel back that attachment.
And bring it up. So, we don't throw it out. We don't throw out the baby with the bathwater. What we do is we use that for inspiration. Because back in the old days, when someone would come in with a sketch, we would have to iterate to kind of get those thoughts out of them as we created the design. Well, now they have those thoughts out. It's on paper. And so now what we need to do is peel back and understand the on underlying kind of philosophy of thought process to that and that then helps us create our what we call our North Star. Okay.
Etienne Nichols: Well, tell me about the North Star. How do you determine that? Because I can almost see somebody bring that picture like, well, this is my North Star. Get to this. You know, I what's what in your mind is the North Star?
Michael Sprauve: So, the North Star in our process is what we feel is for a product to be successful, there needs to be something more than technology. There needs to be an emotional connection with that product. That emotional connection is what triggers what I find is a stickiness. Okay. Sometimes it can be the technology. someone just loves the technology such that, I'm going to sacrifice convenience.
I'm going to sacrifice usability. I'm going to sacrifice all these other pieces because I just love the technology. Okay. And we see that out in the marketplace. But there are others that's like, you know what? I love this emotional connection, what it brings to me. I feel like this is an extension of me. So, one of the things that we do during our early research is we use emotional statements.
To have the client describe what they want their product to be. We don't ask them physical, we ask them things like if your product was sound, what would it sound like? Would it be like a raucous, you know, heavy metal piece, or would it be a classical piece, or would it be something in the middle?
We ask them what color would your product be if someone was to emotionally connect, right? And so, we try to touch on the five senses. And we do this with users as well. Okay. Again, what we try to do is we try to get these emotional cues in non-physical words. And then my team of very talented creatives then take that and what we create is what we call our North Star. Okay. This product will have these attributes. These attributes are something that we use in every step of the way in our design process.
When we start coming up with concept development, we always refer back to the North Star. We always say, does our design concepts fit these emotional attributes and triggers that we're going to? So, a lot of times we will not create a design for design’s sake. We will create a design that matches these North Star. When we move to the engineering phase, we will only engineer things that are relevant.
To this North Star. We don't try to overcreate. We don't try to undercreate. We try to continue that path. Okay. And our project manager, they're the ones in charge of making sure that we adhere to that North Star as we move through process. Same thing with manufacturing.
As we develop our what we call the CMF document, which is we pick out the color, the material, and the finish of the outside housing or whatever it is, we always say, when this is done, does this match what we're looking at? And we will manually we will adjust the manufacturing technique to make sure that we do achieve those. Okay. And so all along the way, we are always making sure that we are looking towards our North Star that we establish at the very beginning to make sure that we don't lose our…
Etienne Nichols: If I go back a little bit to what we were talking about with AI, because that's probably not going to change. but keeping in mind with what you're already talking about with the North Star, if you were to talk or sit with someone who's going to utilize, you know, a design firm for their medical device, you're probably not gonna talk them out of using AI because that's just the world we're in at this point. And maybe that and we kind of joked about is that a good thing, is it a bad thing?
Well, it's just I actually immediately went to the physics as well because that's one of the biggest traits. As a mechanical engineer myself, I'm like, I know they're probably not going to get the K factor on that radius, you know, and or can we injection mold this or does it have to be 3D printed? Sure, it's physically possible, but is there any, you know, there there's lots of economic downside to just creating something that, you know, just yeah, without really thinking about the physics behind it, the divine design for manufacturability.
So, if I were to ask you how if you just had a chance, you're sitting at a cafe with somebody, say, okay, you're about to go talk to a design firm. you're this is the design you have. Well, here are a few things you could do to make both of your lives easier before you ever even talk to that engineer, person, or project manager. What are some things you might give that person or pieces of advice?
Michael Sprauve: So, the first thing is if they're gonna use AI, what I would give them is a checklist of certain things, right? The first thing is described to the AI engine what who the user personas are, right? Have then spent some time, really take the time out to really understand the audience, right? And it's not just the one user persona, okay? I would take it.
From cradle to grave kind of user persona, right? Give that to the AI engine. One of the things that we've seen recently, the AI engines are very capable. You can create a project, you can give it more cathedral concepts, and it's able to kind of digest that. Okay. The other thing is once you give it the personas, I would give it a list of emotional cues, right? I would give them the list of the five senses.
You know, the question. Now I realize I may be putting myself out of business, but you know, this would help inform the AI engine. Okay, as far as that is concerned. And then, you know, ask it to come up with a list of designs based upon these emotional components, right? Maybe give it some physical constraints.
Okay. But really, it's really it I mean, that's what as you pointed out, that's when the engineering comes into it, right? You know, thinking about okay, are the corners radius correctly? Is this gonna be injection moldable? Did they come up with something that really looks good but doesn't make sense from a manufacturing perspective? things like that, you know, and that's what I would start off with and come up with the concept direction. Yeah. Okay. From there.
Etienne Nichols: And so, you talked about that's when the engineering comes in. I love that you said that because the engineering really is the application of physics and science to solve a problem. And you know, some people say, well, this is really over engineered. And every time I hear that phrase, I think, if it's overengineered, then it wasn't engineered. I mean…
Michael Sprauve: Exactly.
I know.
Etienne Nichols: But one of the things you also said was you know, I maybe I'll put myself out of business doing this, but I actually think you're getting ahead of something that's inevitable, really. And yeah, I mean, I actually think people who bring a better problem, it makes it a little bit easier to solve. I mean, one of my mentors told me early on, he said the heart of the problem is the seat of the solution. So, if you really understand the problem, you're gonna be able to solve that problem so much easier.
So, and I think it's a similar situation with I'm sure, you know, it if people really understand what they want to convey, I don't think engineering will ever go out of business. but you know, it's you know, it's changing every day. But someone I what was I gonna say? Well, what I'm really trying to say is it's hard to truly put the real value on someone who's seen hundreds of medical devices or hundreds of times this process has gone through. and that's really the value. The Sherpa who's been up the mountain a hundred times. I mean, we've got GPS on our phones. Why can't I get to the top of Mount Everest by myself? Exactly.
Michael Sprauve: Exactly. You know, that there's that old joke where, you know, company hires this consultant because their machine's broken, and consultant comes in, looks at the machine and puts you know, puts an X right, you know, on the machine and says, hit the mallet right there. Guy hits the mallet and the machine starts working. The guy gives him this massive build. He's like, why, why, why am I paying all this for you know for just hitting the machine?
He says it's because I know where to tell you to hit the machine. Yeah. Right. And really, that's really what our value is. And like I said, you know, I've been in the industry long enough to watch how things have evolved. When I first started off in the industry back at Xerox, we were just getting into 3D CAD. And I mean, ironically, there was a lot of draftsmen that couldn't make that jump.
From 2D to 3D. They just couldn't visualize it. Okay. And now we're making another revolutionary jump, right? And you need to be able to evolve fundamentally, right? Whether you're in the industry, whether you are just in normal walk of life. I've seen that in MedTech, right? I mean, some of the things that some of the machines that we're developing that we have inside development, it's truly phenomenal, some of the things that they're doing.
But at the end of the day, there still are fundamentals and there still needs to be someone that knows where to put the X to hit the machine to get it working. And that's what we believe we continue to do here spec divine spec design.
Etienne Nichols: So, if we kind go and I don't mean to go keep going back and forth, back and forth, but you talked about the North Star, and I can't help but think about that again because my brain is sort of making some connections to earlier. Because we talked about the personas, we got nurses cradle to grave, you know, the surgeons, the actual patients, the regulatory bodies. When you've got a medical device designer or a physician who has an idea or something in his mind, his or her mind.
They they've got that North Star in their mind, you know, what the color what is would taste like if it was ice cream flavor, whatever else, you know, all the different things and the emotions around it. But have you ever f found that, yeah, but they're only looking at it through the surgeon's perspective or the and really they need to think about it from this other perspective. What's the North Star from this angle? What are your thoughts there?
Michael Sprauve: 100%, you know. I will tell you surgeons are very interesting breed. And that is they will always think of new devices to make their life easier. Okay. Probably surgeons are probably other than large companies, surgeons are probably one of the biggest categories that will walk through our doors with, I had this great idea. Yeah.
Let's go for it. Okay. You know, in fact, if I look at my portfolio, I think we have four surgical devices that are surgeon driven. Okay. Which is which is quite phenomenal because to take a medical device from concept, from napkin, all the way to FDA approval, it's a steep price. Okay.
Etienne Nichols: That's a big deal.
Michael Sprauve: Yeah. Okay. And but I've seen surgeons come in with Nathan sketches and succeed from there and it and it ends up being a multi-million-dollar device that they end up selling. But they always look at it from a surgical perspective, right? They don't think about it from the prep to the post. Because honestly, the other thing about surgeons is they enjoy their golf game or they enjoy their downtime. Once they are done, they are done and they're out the door. Okay.
But they don't think about the other people that have to have to take care of the devices that they think are so novel and so brilliant. You know, we're developing this one particular device that surgeon is using pretty serious surgery and very novel device. you know, I think it's gonna be a very successful device. But it was developed by a surgeon. But the reality of it is they put this device on, and they leave the operating room.
The device stays on the patient for forty-eight to seventy-two hours. And so, the nurse has to maintain that, right? And if the nurse, you know, has to maintain it, they haven't even thought about that that user scenario. Okay. So, they came to us with this concept of the device. And it was only from their vantage, from their viewpoint of how easy it would be for me to place it on during surgery. Okay. Yeah. Not, you know, indication that things are still going okay and all of that. So that's a that's an example of and it's more common than uncommon. Yeah.
Etienne Nichols: Well, the regulatory bodies are interesting to me too, because you know, I am living in the US, I have the same American problem every American has, like we're the entire world. Well, that's not really true. There's a whole other world out there. and you know, if you go even if you go with MDSAP, you got Brazil, Australia, Canada, Japan, and then you've got UMDR. we mentioned NMPA, China earlier. And so how do you look at that? Do you is that another persona in your mind or is that just inputs that that could influence the design or ha or does it yes or no?
Michael Sprauve: So, it becomes more of a checklist. Okay. And the checklist really is, you know, and again, it goes back to the client, where is there, where do they want to sell this at? Okay. Most of the serial entrepreneurs, you know, the one-off type of device manufacturers, right? They're just trying to get into the US market. Yeah. Okay. So therefore, they are focused on the US market.
And as long as we divide, you know, design something that meets FDA approval, they're more than happy. Okay. Because in their mind, it's going to be, you know, once I hit the US market, everything else is gravy. Well, as you know, it's a lot more complicated than that. Okay. But they're not willing to pay for that piece. And so, we inform them of it.
We try to point out the differences between you know, if you want to stay stateside, if you even want to sell up in the canoe down in the Mexico, stay in the, you know, the continental North America, there's still challenges with that. If you have any visions of taking over to Europe, let's talk about that. So, we highlight these things, but and it's only when we deal with larger companies is that they're fully aware of this and they already have a targeted rollout plan.
So, I don't deal with it as a new persona. I deal with it more as a checklist. Just like when you get to the engineering component, right? Is this gonna be injection molded? Okay, if it's gonna be injection molded, it needs to follow these design rules, right? If it's going to be stamped sheet metal or if it's gonna be die casted, right? Those are those are rules that will influence the design, but it won't influence the North Star.
Etienne Nichols: Yeah. Okay. That's good. What are some things with design to manufacturing? 'Cause manufacturing is a whole no other animal sometimes. The DFM, the design for manufacturability or however you look at that, when does that come in or is that does I I assume the North Star still applies in that phase?
Michael Sprauve: So, one of the things, again, I'd like to pride myself, and this was this was after years of process at Xerox that this was kind of drummed into me and I carried it throughout my career. And one of the things that I find that is very valuable is having team involved from the very beginning. Okay. Now the amount of involvement is very light, so take the manufacturing engineer.
Right. They will be part of the team during the re user research, during the concept development, concept design, and the engineering. Their role and responsibility grow as the process goes, but they are fully informed at the very beginning and they're aware of that. And so, you say, well, why would you do that? And that is because as we know, DFM is too late at that point. Okay.
You the design is pretty much locked in and now the design for manufacturability becomes a contentious relationship where if they are involved at the very beginning, they are already providing input into the process to make sure that when it gets to that, it's not a contentious relationship, but a very smooth, symbiotic transition from one phase to the next.
Okay, so I always tell people, it's not so much on the MedTech side, even though it does really matter, but it really matters on the consumer side. All of your cost savings are going to come in the concept, development, design, even before we get to engineering. And that's where the manufacturing engineer earns this salt because we understand what it's going to take to manufacture this. And therefore, we know what we need to influence in the very beginning.
With MedTech, one of the biggest hurdles that people run into is the FDA requirements, right? Around material, around form, around safety. So, all those components influence that at the very beginning.
Etienne Nichols: Yeah. Yeah. That makes sense. And I mean, I just a couple of other thoughts keep bubbling up into my mind 'cause we were talking about surgeons and you know, what they think and so after you get to the manufacturability, after you have that, a lot of stuff's pretty locked in. So, I mean those user insights are gonna be incredibly important, prior to that even, prior to that manufacturability standpoint, because it like I said, it's expensive to change things after you manufacture something, after you get the molds all cut, all that sort of thing.
And surgeons are it's you mentioned they're an interesting group. They're also, I mean, they a lot of it's justifiable. They're in pretty stressful situations. They're doing some pretty important stuff. I would expect them to be something of a demanding user group as well. And so, I don't know if you I don't want you to spill any secrets necessarily, but just how you get some of the user insights is still kind of a curiosity to me.
Michael Sprauve: So yes, yes, with surgeons it is they're very precise, right? And they're very hands on. Okay. you know, because I mean ultimately their job is in their control, right? They're it's their hands that are that are that are doing it, right? And so, they always wanna have hands on. So, one of the things that we try to do in our process is we try to prototype very quickly.
Right. Once we as we move into the concept development phase, we will 3D print and we will create physical mock-ups. You know, sometimes there'll be actually operational mock-ups. Obviously, they wouldn't be able to use it in a surgical situation, but they have enough exposure and they have enough experience to where they can now physically handle these things, right? And even before we lock in the design, okay, we try to get their buy-in.
And what we then encourage is for them to take these physical mock-ups or these physical prototypes and to test them out among their surgical team. Again, seeking input, right? We'll ask them, you know, can you talk to your surgical nurses? Can you talk to your post op nurse team? You know, are you comfortable with that? Sometimes they're not comfortable. Sometimes they think they got the best kept secret, and they don't want to share with anybody.
Yeah. So, we were we gently try to persuade them, you know, that it's in their best interest, even if they keep it to a small team, to just get the initial feedback. Because as we pointed out and as you reminded us all, it is very expensive once you commit to tooling. Okay. You know, from there. And so that's some of the things that we try to do to hop is check our North Star.
Okay. Is we've what I like to tell my team is we try to fail rapidly. Okay. And that doesn't mean that we like failing, but again, my experience through all my years is you don't learn from successes. You only learn from failures. So, let's get something physical, let's get it out there, let's get it in their hands, let's figure out what their vision disconnects from our North Star. Let's get all this as fast as possible so that we can then iterate and get to that, you know, compass adjustment as fast as possible.
Etienne Nichols: Well, I love the framework. I think it's an awesome way to do things. iterate quickly and so on. That's it's really, it's a really good framework that you have maintaining that North Star. Of course, you know, the real money is in the execution, the actual ability to do that, which I guess you've proven to do, which is awesome. So really appreciate all the insights. Any last piece of advice or thoughts that you have for somebody who has in mind to get into medical devices, or they have a medical device in their mind, they're planning to do something.
What are your thoughts? Any piece of advice?
Michael Sprauve: Yeah, so the first thing is technology is not the North Star. Okay. we have we've developed a lot of devices that were quite simple, quite simple, and are extremely successful in the medical field. Okay, so it doesn't need to be this technology driven design. That's the first thing.
Right. The other thing I t I tell people is just look at your daily life. Just look at, you know, your routine in the surgical unit. Let's look at your routine in postdoc. You know, and just it doesn't need to be complicated. You know, let's keep it simple. Let's think of something that makes your life or maybe, you know, your surgical team or your postdoc team's life a little bit better. Right?
That's those incremental steps in a device can mean the world, especially in today's world, where the demand is just increasing, the support the staffing is getting thinner and thinner, you know, it's really doesn't need to be the next microsurgical robotic device. Okay. It doesn't need to be some AI driven supercomputer or robot doing something, it can be something as simple as a simple, you know, I don't wanna give away some of the devices we're working, but you know. Yeah.
Etienne Nichols: Like the job pole noodle. Whoever invented that. I wish I could have been that guy.
Michael Sprauve: Exactly.
Exactly. You know? But yeah, that’s really the key thing is really just look at your day to day and see, man, if I just improved upon this little step, it will make a big difference.
Etienne Nichols: Yeah. Yeah. That's good. Well, I appreciate it. Where can people find you to learn more about what you're working on?
Michael Sprauve: So, this is my quick plug. Our website is WW Spec Design. That's S P-E-C-K design all one-word dot com. You know, if you go to our website, we have a bunch of different case studies, both medical and non-medical, consumer, industrial, life science. That's probably one of the bigger growth areas. we do everything from OTC over the counter: medical devices, lifestyle devices, to invasive Class II devices. we have a complete team of creatives, engineers, manufacturing support. we have developed product that is fabricated here in North America. We also worked with companies that take fabrication over to Asia.
We're very flexible. We have clients that are based in the MidEast. We have clients that are based in Europe, in the EU, we have clients based here in the United States. since COVID, we have become very flexible and very comfortable with being able to work remotely and just making it feel like we're the extension of the engineering group or we're part of their engineering team. So that's where you can find us. We'd love to be able to talk device and actually if you have questions or you know, looking for some suggestions on where to go from here, that's you know, just reach out to us and we love talking. And you can tell I love talking.
Etienne Nichols: Great. Real well, I really appreciate it, Michael. This has been a fun conversation. And that's, you know, it's interesting to hear how technology is changing the actual design of our medical devices and the process through which, you know, we design those things. So, I really appreciate you sharing that and sharing some of the little bit of behind the curtain of how you do things. That's always interesting as well to hear from me. So, thanks so much. Really appreciate you coming on the show. Those of you listening, thank you so much for listening to the Global Medical Device Podcast.
We'll let you guys get back to it, but until next time, take care and we'll see you then.
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.